MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 20GA (3F) 0.95MM X 65CM

Model Number	384156
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.According to the product experience report, there was no sample available for review.However, there was an image and video provided.Based on the visual evidence, the catheter tubing appeared to be shorter than the required length, confirming the complaint for breakage.A definite root cause for the breakage could not be determined without the sample to review.A clear view of the breakage site was not provided.It could not be determined from the visual evidence if a tensile force had been applied to the catheter or if tape strips had been applied to the catheter as the ifu cautions against as this could compromise the strength and integrity of the tubing.There have been no other complaints regarding this issue with this lot number.Since a definite root cause could not be established and there have been no other complaints regarding this issue with this lot number, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.
Event or Problem Description
Catheter 3.0 fr (lot:11371098 val:06/04/2024) and introducer #4 (lot:22.05.117565 val:05/30/2025) argon brand.; e jugular vein chosen and catheter cut at 16cm; performed surgical brushing of the team with chlorhexidine degerming; - surgical apron placed;- performed degerming with chlorhexidine degerming and alcoholic chlorhexidine; prepared all table with material to be performed;- successfully performed, 01 puncture inside the blood vessel with good venous return, introduced 16cm of catheter with no signs of resistance, at the end of the introduction performed flush with 0.9% solution;- when breaking the introducer, 5 cm of catheter was returned, and it was tried to be introduced again, but presented resistance.When removing the catheter completely, only 6 cm of catheter was evaluated, remaining 10 cm inside the blood vessel.The on duty physician dr.(b)(6) was notified, a chest x-ray was performed, and she contacted the hemodynamics on duty for management definition (catheter lodged in the vena cava).(catheter lodged in the vena cava) -waiting for an echocardiogram to be performed by dr a.- an echocardiogram will be performed later.It will be forwarded to the hemodynamics on october 17 for removal.".

• Brand Name: FIRST PICC S/L 20GA (3F) 0.95MM X 65CM
• Common Device Name: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 16277137
• Report Number: 0001625425-2023-00950
• Device Sequence Number: 6748331
• Product Code: FOZ
• UDI-Device Identifier: 00886333209675
• UDI-Public: 00886333209675
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2024
• Device Model Number: 384156
• Device Catalogue Number: 384156
• Device Lot Number: 11371098
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown